MAUDE Adverse Event Report: CORCYM CANADA CORP. PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number PVF-S

Device Problem Collapse (1099)

Patient Problem Insufficient Information (4580)

Event Date 11/22/2023

Event Type  Injury  

Event Description

Manufacturer was informed that on (b)(6) 2023, a perceval plus valve size s was implanted and upon coming off of pump, valve appeared to have buckled onto itself in the echo.It was reported that the valve was too large for the annulus.As such, the valve was explanted, and a stented valve was implanted.Reportedly, patien'ts annulus was 19.8 per the ct analysis report.As reported, patient ultimately was placed on ecmo.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• MDR Report Key: 18387807
• MDR Text Key: 331294452
• Report Number: 3019892983-2023-01024
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000795
• UDI-Public: (01)00896208000795(240)PVF-S(17)270317
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/26/2023,12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVF-S
• Device Catalogue Number: PVF-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/26/2023
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/26/2023
• Date Manufacturer Received: 11/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention